Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora

Not Applicable

Terminated

• Conditions: Healthy Volunteers

• Registration Number: NCT00190151
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Bacterial resistance to antibiotics has been a growing therapeutic problem since the late 1980s. Resistant strains of pathogenic bacteria can arise through initial selection of resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the commensal flora will be assessed in 48 healthy volunteers receiving variable doses of ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic characteristics of ciprofloxacin.

Detailed Description

Pharmacokinetic/Pharmacodynamic Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora Bacterial resistance to antibiotics has been a growing therapeutic problem since the late 1980s. Resistant strains of pathogenic bacteria can arise through initial selection of resistant strains in the commensal flora. The emergence of fluoroquinolone resistance in the commensal flora will be assessed in 48 healthy volunteers receiving variable doses of ciprofloxacin during 14 days. Emergence of resistance will be correlated to pharmacokinetic characteristics of ciprofloxacin.

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Last Update Submitted: 2012-09-17
• Last Update Posted: 2012-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• healthy volunteers

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Occurrence of bacterial resistance in commensal flora

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic/pharmacodynamic relationship

Trial Locations

Locations (1)

Hôpital Bichat Claude Bernard, 46 rue Henri Huchard; 🇫🇷 Paris, France